{"active_ingredient":["Drug Facts Active Ingredients (in each tablet) Dextromethorphan HBr, 28 mg Guaifenesin, 388 mg Phenylephrine HCl, 10 mg"],"ask_doctor":["Ask a doctor before use if you have: heart disease excessive phlegm (mucus) high blood pressure diabetes thyroid disease difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema"],"do_not_use":["Do not use more than the recommended dosage or if you are now taking a prescription Monoamine Oxidase Inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s Disease), or for 2 weeks after stopping the MAOI drug. If you are uncertain whether your prescription drug contains an MAOI, ask a health professional."],"dosage_and_administration":["Directions • Adults and Children 12 years and over: Take 1 tablet every 6 to 8 hours. Do not take more than 4 tablets in a 24 hour period. • Children 6 to 12 years of age: Take 1/2 tablet every 6 to 8 hours. Do not take more than 2 tablets in a 24-hour period. • Children under 6 years of age: Consult a physician."],"effective_time":"20260723","id":"5746a790-450c-79d7-e063-6394a90a7077","inactive_ingredient":["Inactive ingredients Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Silicate, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Mineral Oil, Polyvinylpyrrolidone, Silica, Sodium Lauryl Sulfate, Stearic Acid, Titanium Dioxide and Triacetin."],"indications_and_usage":["Uses Temporarily relieves the symptoms associated with a cough, the common cold, hay fever, or other upper respiratory allergies. Helps loosen phlegm (mucus), loosens nasal congestion, thin bronchial secretions, drain bronchial tubes, make coughs more productive, clear stuffy nose, clear nasal passageways, and shrinks swollen membranes."],"keep_out_of_reach_of_children":["Keep out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center immediately."],"openfda":{"application_number":["M012"],"brand_name":["Giltuss Cough and Cold"],"generic_name":["DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL"],"is_original_packager":[true],"manufacturer_name":["Gil Pharmaceutical Corp"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["58552-331-20"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["58552-331"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["2167784"],"spl_id":["5746a790-450c-79d7-e063-6394a90a7077"],"spl_set_id":["8590fcc9-c0dd-f43b-e053-2991aa0a692e"],"substance_name":["GUAIFENESIN","DEXTROMETHORPHAN HYDROBROMIDE","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["495W7451VQ","9D2RTI9KYH","04JA59TNSJ"]},"package_label_principal_display_panel":["MAXIMUM STRENGTH Giltuss ® COUGH & COLD 20 TABLETS SUGAR FREE. DYE FREE. PRESERVATIVE FREE. RELIEVES COUGH AND COLD CHEST CONGESTION LOOSENS PHLEGM AND MUCUS STUFFY NOSE NASAL CONGESTION SINUS PRESSURE 58552-331 Cough Cold Tabs 10-11-2018"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Antitussive Expectorant Nasal Decongestant"],"questions":["Questions or Comments? Call 787-848-9114 , Mon.-Fri. 9:00 a.m. thru 5:00 p.m. EST. Call your doctor for medical advice in the event of side effects."],"set_id":"8590fcc9-c0dd-f43b-e053-2991aa0a692e","spl_product_data_elements":["Giltuss Cough and Cold Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE LIGHT MINERAL OIL POVIDONE K30 SILICON DIOXIDE SODIUM LAURYL SULFATE STEARIC ACID TITANIUM DIOXIDE TRIACETIN TALC CROSCARMELLOSE SODIUM GILGIL;303303"],"spl_unclassified_section":["Other information Store at room temperature, USP Do not use if blister seal is broken","MANUFACTURED FOR GIL PHARMACEUTICAL CORP. PONCE, PUERTO RICO 00717-1565 giltuss.com"],"stop_use":["Stop use and ask a doctor if: nervousness, dizziness, or sleeplessness occurs symptoms are accompanied by fever, rash, persistent headache, or excessive phlegm (mucus) cough and congestion do not improve within 7 days or tend to recur These could be signs of a serious condition."],"version":"8","warnings":["Warnings Do not use more than the recommended dosage or if you are now taking a prescription Monoamine Oxidase Inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s Disease), or for 2 weeks after stopping the MAOI drug. If you are uncertain whether your prescription drug contains an MAOI, ask a health professional. Ask a doctor before use if you have: heart disease excessive phlegm (mucus) high blood pressure diabetes thyroid disease difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema Stop use and ask a doctor if: nervousness, dizziness, or sleeplessness occurs symptoms are accompanied by fever, rash, persistent headache, or excessive phlegm (mucus) cough and congestion do not improve within 7 days or tend to recur These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center immediately."]}